HBM9027 / Harbour BioMed - LARVOL DELTA

Comparison of receptor occupancy and optimal doses of PD1xCD40 and PDL1xCD40 bispecific antibodies using physiologically based pharmacokinetic modeling (SITC 2024) - "For PD1xCD40 BsAb kinetic parameters, YH008 antibody was used; 1 for PDL1xCD40 BsAb, HBM9027 antibody.2 Results The model was validated using PK data for monospecific antibodies against PD1 (pembrolizumab, nivolumab), PDL1 (avelumab, durvalumab, atezolizumab), and CD40 (selicrelumab, Chi Lob 7/4, BI 655064), and showed good agreement with clinical data. Conclusions The developed PBPK model integrating data on immune cell levels, target expression, and binding parameters of PD1xCD40 and PDL1xCD40 BsAbs predicts PK and receptor occupancy of the antibodies in tumor and plasma. The model shows that higher doses of PDL1xCD40 BsAb are required for maximal engagement of target molecules compared to PD1xCD40 BsAb."

IO biomarker • PK/PD data • Hematological Malignancies • Oncology

Harbour BioMed Announces IND Clearance for HBM9027 in the U.S. (PRNewswire) - "Harbour BioMed...announced that the Company has been granted the clearance of Investigational New Drug (IND) from the Food and Drug Administration (FDA) of the United States to initiate the first-in-human (FIH) clinical trial in the U.S. for bispecific antibody HBM9027. This is a phase I study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of HBM9027 in subjects with advanced solid tumors."

IND • New P1 trial • Oncology • Solid Tumor

Harbour BioMed Reports Full Year 2022 Financial Results (PRNewswire) - "In addition, HBM7022 (CLDN18.2xCD3), HBM7004 (B7H4x4-1BB), HBM9027 (PD-L1xCD40), HBM9033 (MSLN ADC), HBM1047 (CD200R1) and HBM9014 (LIFR) are all preclinical stage products in the company's pipeline. With the efficient output of the technology platforms as well as the rich expertise of our R&D team, the Company aims to file at least one IND each year moving forward."

IND • Oncology • Solid Tumor

Harbour BioMed Announces 2022 Interim Results (PRNewswire) - "HBM9027 is currently in preclinical studies and is expected to be submitted for an IND application in 2023. A number of innovative global programs are expected to file IND by the end of 2022, including HBM1020, HBM1022, and HBM1007."

IND • Oncology

Harbour BioMed Announces Poster Presentation on the Novel Bispecific Antibody PD-L1xCD40 at Upcoming American Association for Cancer Research (AACR) Annual Meeting (PRNewswire) - "Harbour BioMed...announced that the poster presentation on HBM9027, a novel PD-L1xCD40 bispecific antibody with excellent efficacy and safety profile for cancer therapy...The novel PD-L1xCD40 bispecific antibody was generated by Harbour HBICE® platform. It demonstrated unique mechanism of action, potent anti-tumor efficacy and superior safety profile, which is an innovative DC/myeloid cell bispecific engager for the next generation of immunotherapies. (i) Mediates both PD-1/PD-L1 inhibitory pathway and CD40 agonistic pathway to achieve synergistic anti-tumor immune responses (ii) Combination effects on both myeloid cells and lymphocytes in the innate and adaptive immune systems by stimulating APC cells and relieving the immunosuppression on T cells. (iii) Potent in vivo anti-tumor efficacy and remarkable in vivo stability with long half-life (iv) Preclinical toxicology studies indicated that the crosslinking-dependent CD40 activation can overcome the liver and..."

Preclinical • Oncology